Effect of Helmet Noninvasive Ventilation vs Usual Respiratory Support on Mortality Among Patients With Acute Hypoxemic Respiratory Failure Due to COVID-19
Authors: Yaseen M. Arabi, Sara Aldekhyl, Saad Al Qahtani, Hasan M. Al-Dorzi, Sheryl Ann Abdukahil, Mohammed Khulaif Al Harbi, Eman Al Qasim, Ayman Kharaba, Talal Albrahim, Mohammed S. Alshahrani, Abdulrahman A. Al-Fares, Ali Al Bshabshe, Ahmed Mady, Zainab Al Duhailib, Haifa Algethamy, Jesna Jose, Mohammed Al Mutairi, Omar Al Zumai, Hussain Al Haji, Ahmed Alaqeily, Zohair Al Aseri, Awad Al-Omari, Abdulaziz Al-Dawood, Haytham Tlayjeh, Mohammad Al Obaidi, Faisal Al Baseet, Omar Al Fares, Abdullah Al Suayb, Yassin Ismaiel, Rami Al Khalid, Hashem Sammanoudi, Edgardo Tabhan, Musharaf Sadat, Wedyan Al Wehaibi, Lara Afesh, Felwa Bin Humaid, Victoria Burrows, Amal Matroud, Brintha Naidu, Mohamed Hussien, Ahmad AlFar, Salman Al Asiri, Anas Al Solami, Laila Perlas Asonto, Charlene Mapusao, Arivukodhi Muthu, Abdulaziz Saad AlGhamdi, Carmelo Angala, Munir Mustafa Aldammad, Nasser M Alwadai, Om Prakash Palanivel, Naif Abdulrahman Aldosari, Khalid Abdullah Alreyes, Arul Prasath Lakshmanan, Alzahra Al Obaed, Mobarak Almushhen, Fhausia Hali, Ika Fibriantini, Bobby Rose Marasigan, Katrina Baguisa, Mahmoud Abu Riash, Haya Alotaimeen, Rozeena Huma, Saleh Ali Almahwi, Sheryl S Lugue, Liyakhat Khan, Moataz Gabr, Saleh Baaziz, Shehla Nuzhat, Ahmed Almumin, Fahad Alhaj, James Albert, Israr Khan, Muhammad Ayaz, Jamal Chalabi, Fahad Al-Hameed, Abdulhadi Bin Eshaq, Rakan Alqahtani, Omar Alnafel
Journal: JAMA (2022)

Importance Helmet noninvasive ventilation has been used in patients with COVID-19 with the premise that helmet interface is more effective than mask interface in delivering prolonged treatments with high positive airway pressure, but data about its effectiveness are limited. Objective To evaluate whether helmet noninvasive ventilation compared with usual respiratory support reduces mortality in patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. Design, Setting, and Participants This was a multicenter, pragmatic, randomized clinical trial that was conducted in 8 sites in Saudi Arabia and Kuwait between February 8, 2021, and November 16, 2021. Adult patients with acute hypoxemic respiratory failure (n = 320) due to suspected or confirmed COVID-19 were included. The final follow-up date for the primary outcome was December 14, 2021. Interventions Patients were randomized to receive helmet noninvasive ventilation (n = 159) or usual respiratory support (n = 161), which included mask noninvasive ventilation, high-flow nasal oxygen, and standard oxygen. Main Outcomes and Measures The primary outcome was 28-day all-cause mortality. There were 12 prespecified secondary outcomes, including endotracheal intubation, barotrauma, skin pressure injury, and serious adverse events. Results Among 322 patients who were randomized, 320 were included in the primary analysis, all of whom completed the trial. Median age was 58 years, and 187 were men (58.4%). Within 28 days, 43 of 159 patients (27.0%) died in the helmet noninvasive ventilation group compared with 42 of 161 (26.1%) in the usual respiratory support group (risk difference, 1.0% [95% CI, −8.7% to 10.6%]; relative risk, 1.04 [95% CI, 0.72-1.49]; P = .85). Within 28 days, 75 of 159 patients (47.2%) required endotracheal intubation in the helmet noninvasive ventilation group compared with 81 of 161 (50.3%) in the usual respiratory support group (risk difference, −3.1% [95% CI, −14.1% to 7.8%]; relative risk, 0.94 [95% CI, 0.75-1.17]). There were no significant differences between the 2 groups in any of the prespecified secondary end points. Barotrauma occurred in 30 of 159 patients (18.9%) in the helmet noninvasive ventilation group and 25 of 161 (15.5%) in the usual respiratory support group. Skin pressure injury occurred in 5 of 159 patients (3.1%) in the helmet noninvasive ventilation group and 10 of 161 (6.2%) in the usual respiratory support group. There were 2 serious adverse events in the helmet noninvasive ventilation group and 1 in the usual respiratory support group. Conclusions and Relevance Results of this study suggest that helmet noninvasive ventilation did not significantly reduce 28-day mortality compared with usual respiratory support among patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. However, interpretation of the findings is limited by imprecision in the effect estimate, which does not exclude potentially clinically important benefit or harm. Trial Registration ClinicalTrials.gov Identifier: NCT04477668